VESSEL CLOSURE DEVICES AND METHODS
A vessel closure device comprising a proximal end includes a first actuator, a distal end including a suturing mechanism, and first and second needles associated with the suturing mechanism. At least one of the first and second needles is coupled to the first actuator. The suturing mechanism is activated within the vessel through an opening in the wall of the vessel. The first and second needles are directed through the vessel wall adjacent to the opening to direct a tensile member adjacent to the opening for closing and sealing the opening.
This application claims priority to U.S. Provisional Patent Application Ser. No. 63/124,400, filed Dec. 11, 2020, and U.S. Provisional Patent Application Ser. No. 63/191,017, filed May 20, 2021, the disclosures of which are incorporated herein by reference in their entirety.
TECHNICAL FIELDThe present invention generally relates to closure devices and methods for sealing punctures or other openings in blood vessels, such as the common carotid artery made during a direct access approach for neurological therapy. The devices and methods may be used in the course of other therapies or surgical procedures as well.
BACKGROUNDVascular access for neuro-therapy is traditionally performed through the femoral artery or radial access approaches. For vascular access to the brain using a traditional approach, neuro-therapy devices must navigate through lengthy tortuous segments of the anatomy to gain access to the therapeutic site. The Direct Carotid Artery Puncture (DCP) method for accessing the common carotid artery allows doctors quicker access to the brain and eliminates the need for devices that must traverse the typical femoral interventional track. Given these benefits, it would be further advantageous to seal the puncture from this DCP method in a more efficient and effective manner.
To close and seal a DCP, doctors currently may apply a suture manually prior to the access or may simply apply direct pressure to the site after intervention until the vessel seals itself. The latter method relies on blood coagulation at the puncture site. Therefore, the time period necessary for closing the puncture with direct pressure may be quite lengthy. Also, this method may be less than effective because of the lack of suitable anatomy in the vicinity of the common carotid artery against which the pressure may be applied. Moreover, the common carotid artery carries blood at a high pressure (100 to 200 mmHg) which further complicates the ability to effectively close the carotid puncture with current methods.
SUMMARYGenerally, a vessel closure device is provided and includes a proximal end with a first actuator, a distal end including a suturing mechanism, and first and second needles associated with the suturing mechanism. At least one of the first and second needles is coupled to the first actuator. The suturing mechanism is activated within the vessel through an opening in the wall of the vessel and the first and second needles are directed through the vessel wall adjacent to the opening to direct a tensile member adjacent to the opening for closing and sealing the opening.
In some embodiments, the vessel closure device may have a second actuator coupled to the suturing mechanism for moving the suturing mechanism into an activated orientation. The suturing mechanism may have a pivotal element capable of being moved into a deployed orientation within the vessel by the second actuator.
In alternate or additional aspects, the vessel closure device may include a handle and an elongate shaft coupled between the handle and the suturing mechanism. The first actuator may be carried by the handle. The first actuator of the vessel closure device may be spring-biased into a position for retracting at least one of the first and second needles.
In alternate embodiments, the vessel closure device may include a second actuator and the first needle may be coupled to the first actuator and the second needle may be coupled to the second actuator. The second actuator may be spring-biased into a position for retracting the second needle.
In another illustrative embodiment, a vessel closure device includes a proximal end with a handle with first and second actuators. The device also includes first and second needles, where at least one of the first and second needles is coupled to the first actuator. A distal end of the device includes a suturing mechanism and the suturing mechanism includes a pivotal element coupled to the second actuator. The pivotal element is activated within the vessel through an opening in the wall of the vessel while the pivotal element is in a first orientation. The second actuator is used to reorient the pivotal element into a second, deployed orientation. The first and second needles are directed through the vessel wall adjacent to the opening with the first actuator to direct a tensile member adjacent to the opening for closing and sealing the opening.
In some embodiments, an elongate shaft may be coupled between the handle and the suturing mechanism, and the first actuator and the second actuator may be carried by the handle of the vessel closure device. The first actuator may be spring-biased into a position for retracting at least one of the first and second needles. The second actuator may be spring-biased into a position for moving the pivotal element into the first orientation.
In some embodiments, the vessel closure device may include a third actuator with the first needle coupled to the first actuator and the second needle coupled to the third actuator. The third actuator may be spring-biased into a position for retracting the second needle.
In alternate or additional aspects, the deployed orientation of the vessel closure device may be angled. The suturing mechanism may include a flexible coupling member having first and second ends with the first end being capable of coupling to the first needle and the second end being capable of coupling to the second needle. The first needle of the vessel closure device may include a detachable tip coupled to the tensile member. The vessel closure device include at least one tab coupled to the handle configured to accommodate a user's finger.
In alternate or additional aspects, the vessel may be a blood vessel and the vessel closure device may include an introducer sheath through which the suturing mechanism is directed into the blood vessel. The sheath may then be withdrawn from the blood vessel with the suturing mechanism remaining in the blood vessel thereby inhibiting blood from exiting the blood vessel through the opening.
In another illustrative embodiment, a vessel closure device for closing and sealing an opening in a blood vessel includes a suturing mechanism deployable into the vessel interior, at least one needle and a tensile member engaged with the suturing mechanism for closing the opening, and an introducer sheath through which the suturing mechanism is directed to enter the opening prior to closing the opening.
A method of closing an opening in a vessel is provided and includes directing a suturing mechanism through the opening into the vessel interior. A tensile member is directed through the vessel wall adjacent to the opening using the suturing mechanism. The suturing mechanism is withdrawn and the tensile member is tightened to close the opening in the vessel.
The method may include additional or alternative steps or features. For example, directing the tensile member through the vessel wall may further include directing at least one needle through the vessel wall. The vessel, for example, may be a blood vessel, and the method may include directing an introducer sheath into an opening in the blood vessel and directing the suturing mechanism through the introducer sheath and into the interior of the blood vessel. Withdrawing the introducer sheath from the blood vessel with the suturing mechanism remaining in the blood vessel may inhibit blood from exiting the blood vessel through the opening. A pivotal element of the suturing mechanism may be activated into a deployed orientation after the suturing mechanism is positioned within the interior of the vessel. The deployed orientation may be an angled orientation. The suturing mechanism may include a flexible coupling member with first and second ends, and the method may include coupling a first needle to the first end and a second needle to the second end of the coupling member. The method may further include retracting the first and second needles and pulling the tensile member through the vessel wall.
The device disclosed herein generally allows a single-suture closure of a blood vessel, such as the common carotid artery or another vessel, via a minimally invasive percutaneous approach. There are various non-limiting aspects that may be used alone or in any desired combination. The suturing device may be tracked through an introducer sheath thereby allowing an internal exchange of the suturing device and the introducer sheath. This will inhibit (that is, eliminate, or at least substantially reduce), blood loss normally experienced during a typical device exchange as a result of the high blood pressures found in the common carotid artery. These pressures may be 100 mmHg to 200 mmHg or more. In comparison, typical arterial pressures in a femoral or wrist exchange are in the range of 80 mmHg to 160 mmHg. The suturing device may generally include a proximally located handle, suture needles, sutures or other tensile members, suture transfer mechanisms and, optionally, a blood flow visual indicator. As used herein to describe various embodiments from the perspective of a user of a suturing device, “proximal” may refer to a direction generally towards the user of the device, while “distal” may refer to a direction generally away from the user of the device. The sutures may be percutaneously routed through the dermis skin layer and the vessel wall without affecting the epidermis or outer skin layer.
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The slide actuator 20 is then mechanically locked into position in a suitable manner, such as by being moved within a “J” or “L” slot in the handle 12 as shown best in
Releasing or moving the slide actuator 20 in a forward or distal direction will allow the pivotal element 24 to pivot from the deployed orientation shown in
While the pivotal element 24 is in the deployed, angled orientation as shown in
The tabs 102 are aligned along the longitudinal axis of the generally cylindrical body of the handle 12′″ and are positioned approximately opposite each other on the top and bottom of the handle 12′″ as shown in
While the present invention has been illustrated by the description of specific embodiments thereof, and while the embodiments have been described in considerable detail, it is not intended to restrict or in any way limit the scope of the appended claims to such detail. The various features described herein may be used alone or in any combination within and between the various embodiments. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope or spirit of the general inventive concept.
Claims
1. A vessel closure device, comprising:
- a proximal end including a first actuator;
- a distal end including a suturing mechanism; and
- first and second needles associated with the suturing mechanism;
- wherein at least one of the first and second needles is coupled to the first actuator; and
- wherein the suturing mechanism is activated within the vessel through an opening in the wall of the vessel and the first and second needles are directed through the vessel wall adjacent to the opening to direct a tensile member adjacent to the opening for closing and sealing the opening.
2. The vessel closure device of claim 1, further comprising:
- a second actuator coupled to the suturing mechanism for moving the suturing mechanism into an activated orientation, and
- wherein the suturing mechanism comprises a pivotal element capable of being moved into a deployed orientation within the vessel by the second actuator.
3. The vessel closure device of claim 2, wherein the deployed orientation is an angled orientation.
4. The vessel closure device of claim 1, wherein the suturing mechanism further comprises a flexible coupling member having first and second ends, the first end being capable of coupling to the first needle and the second end being capable of coupling to the second needle.
5. The vessel closure device of claim 1, wherein the first needle includes a detachable tip coupled to the tensile member.
6. The vessel closure device of claim 1, further comprising:
- a handle; and
- an elongate shaft coupled between the handle and the suturing mechanism;
- wherein the first actuator is carried by the handle.
7. The vessel closure device of claim 6, further comprising at least one tab coupled to the handle,
- wherein the tab is configured to accommodate a user's finger.
8. The vessel closure device of claim 1, wherein the first actuator is spring-biased into a position for retracting at least one of the first and second needles.
9. The vessel closure device of claim 1, wherein the vessel further comprises a blood vessel and the vessel closure device further comprises an introducer sheath through which the suturing mechanism is directed into the blood vessel wherein the sheath can then be withdrawn from the blood vessel with the suturing mechanism remaining in the blood vessel thereby inhibiting blood from exiting the blood vessel through the opening.
10. The vessel closure device of claim 1, further comprising a second actuator, wherein the first needle is coupled to the first actuator, and the second needle is coupled to the second actuator.
11. The vessel closure device of claim 10, wherein the second actuator is spring-biased into a position for retracting the second needle.
12. A vessel closure device, comprising:
- a proximal end including a handle with first and second actuators;
- first and second needles, wherein at least one of the first and second needles is coupled to the first actuator; and
- a distal end including a suturing mechanism, the suturing mechanism including a pivotal element coupled to the second actuator;
- wherein the pivotal element is activated within the vessel through an opening in the wall of the vessel while the pivotal element is in a first orientation and the second actuator is used to reorient the pivotal element into a second, deployed orientation, and the first and second needles are directed through the vessel wall adjacent to the opening with the first actuator to direct a tensile member adjacent to the opening for closing and sealing the opening.
13. The vessel closure device of claim 12, wherein the deployed orientation is an angled orientation.
14. The vessel closure device of claim 13, wherein the suturing mechanism further comprises a flexible coupling member having first and second ends, the first end being capable of coupling to the first needle and the second end being capable of coupling to the second needle.
15. The vessel closure device of claim 12, wherein the first needle includes a detachable tip coupled to the tensile member.
16. The vessel closure device of claim 13, further comprising an elongate shaft coupled between the handle and the suturing mechanism, wherein the first actuator and the second actuator are carried by the handle.
17. The vessel closure device of claim 12, wherein the first actuator is spring-biased into a position for retracting at least one of the first and second needles.
18. The vessel closure device of claim 12, wherein the second actuator is spring-biased into a position for moving the pivotal element into the first orientation.
19. The vessel closure device of claim 12, wherein the vessel further comprises a blood vessel and the vessel closure device further comprises an introducer sheath through which the suturing mechanism is directed into the blood vessel wherein the sheath can then be withdrawn from the blood vessel with the suturing mechanism remaining in the blood vessel thereby inhibiting blood from exiting the blood vessel through the opening.
20. The vessel closure device of claim 12, further comprising a third actuator, wherein the first needle is coupled to the first actuator, and the second needle is coupled to the third actuator.
21. The vessel closure device of claim 20, wherein the third actuator is spring-biased into a position for retracting the second needle.
22. The vessel closure device of claim 12, further comprising at least one tab coupled to the handle,
- wherein the tab is configured to accommodate a user's finger.
23. A vessel closure device for closing and sealing an opening in a vessel, comprising:
- a suturing mechanism deployable into the vessel interior;
- at least one needle and tensile member engaged with the suturing mechanism for closing the opening; and
- an introducer sheath through which the suturing mechanism is directed to enter the opening prior to the closing the opening.
24. A method of closing an opening in a vessel, comprising:
- directing a suturing mechanism through the opening into the vessel interior;
- directing a tensile member through the vessel wall adjacent to the opening using the suturing mechanism;
- withdrawing the suturing mechanism; and
- tightening the tensile member to close the opening in the vessel.
25. The method of claim 24, wherein directing the tensile member through the vessel wall further comprises directing at least one needle through the vessel wall.
26. The method of claim 24, wherein the vessel further comprises a blood vessel, and the method further comprises:
- directing an introducer sheath into an opening in the blood vessel;
- directing the suturing mechanism through the introducer sheath and into the interior of the blood vessel; and
- withdrawing the introducer sheath from the blood vessel with the suturing mechanism remaining in the blood vessel thereby inhibiting blood from exiting the blood vessel through the opening.
27. The method of claim 24, further comprising:
- activating a pivotal element of the suturing mechanism into a deployed orientation after the suturing mechanism is positioned within the interior of the vessel.
28. The method of claim 24, wherein the deployed orientation is an angled orientation.
29. The method of claim 24, wherein the suturing mechanism further comprises a flexible coupling member having first and second ends, and the method further comprises:
- coupling a first needle to the first end;
- coupling a second needle to the second end;
- retracting the first and second needles; and
- pulling the tensile member through the vessel wall.
Type: Application
Filed: Dec 9, 2021
Publication Date: Jun 16, 2022
Inventors: Quinton Wiebe (Davie, FL), Brad D. Aurilia (Coral Springs, FL), Nicholas Shattuck (Davie, FL), Daniel Sablyak (Sunrise, FL)
Application Number: 17/546,947